Diffusion Tensor Breast MRI (DTI)

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT02812589

Collaborator

(none)

267

Enrollment

Location

Arm

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The breast MRI is used in the preoperative scenario to evaluate the extension of a newly diagnosed breast cancer and to screen the contralateral breast. The scan consists of a series of images taken after the use of intravascular contrast media that may detect areas of enhancement that look malignant, but are actually benign tissue, producing a false positive result. The investigators aim to evaluate a novel MRI sequence of images that does not use contrast, diffusion tensor imaging (DTI). Addition of DTI sequence does not add significantly to the time of standard breast MRI exam. This novel technique provides improved detection of tissue microstructure and is able to differentiate malignant from benign tumor. Hence, the investigators hypothesize that DTI may decrease the false positive rate when compared with standard dynamic contrast-enhanced (DCE) MRI.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Diffusion tensor imaging (DTI) in Breast MRI	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

267 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Improving the Specificity of Breast MRI Through Diffusion Tensor Breast MRI (DTI)

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Apr 1, 2020

Actual Study Completion Date :

Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diffusion tensor imaging (DTI) in breast MRI	Other: Diffusion tensor imaging (DTI) in Breast MRI

Arm

Intervention/Treatment

Experimental: Diffusion tensor imaging (DTI) in breast MRI

Other: Diffusion tensor imaging (DTI) in Breast MRI

Outcome Measures

Primary Outcome Measures

Validate DTI as a valuable adjunct to improve lesion characterization on breast MRI by using the difference in recall rates [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female of any race, ethnicity and lifetime risk.
Eighteen years or older.
Known recent diagnosis of a breast cancer and normal clinical breast exam of the contralateral side.
Self-detected lump suspicious for breast cancer that it has not been biopsied yet.

Exclusion Criteria:

Inability to understand the consent form
Pregnant or nursing
Currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention
Physically unable to lie down on her belly for at least 10 minutes.
Have had benign needle biopsy of the breast performed within 3 months, or breast surgery within 1 year prior to MRI exam.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Cancer Centre, University Health Network, 610 University Ave.	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator: Anabel Scaranelo, MD, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT02812589

Other Study ID Numbers:

13-6856-CE

First Posted:

Jun 24, 2016

Last Update Posted:

Apr 13, 2021

Last Verified:

Apr 1, 2021

Keywords provided by University Health Network, Toronto

MRI

Study Results

No Results Posted as of Apr 13, 2021